BASKING RIDGE, N.J. (January 18, 2018) – Caladrius Biosciences, Inc. (NASDAQ:CLBS) (“Caladrius” or the “Company”), a development-stage biopharmaceutical company with multiple technology platforms targeting autoimmune and select cardiology indications, announces the completion of enrollment in The Sanford Project: T-Rex Study, a prospective, randomized, placebo-controlled, double-blind Phase 2 clinical trial of 110 patients to evaluate the safety and efficacy of the Company’s CLBS03 as a treatment for recent-onset type 1 diabetes (T1D).
CLBS03 is a personalized autologous cell therapy consisting of each patient's own regulatory T cells, or Tregs, which have been expanded in number and functionally enhanced by a proprietary method developed through a collaboration with Jeffrey Bluestone, Ph.D. and renowned researchers at the University of California, San Francisco. Caladrius holds exclusive rights to an international portfolio of issued and pending patents related to this product.
CLBS03 as a treatment for T1D has U.S. Food and Drug Administration (FDA) Orphan Drug designation, European Medicine Agency Advanced Therapeutic Medicinal Product classification and FDA Fast Track designation, which represents the first T1D program to receive this distinction.
“Completion of enrollment in the landmark T-Rex study is a significant achievement for Caladrius. This program is supported by earlier work conducted by leaders in the field who demonstrated Treg cell therapy to be well tolerated, durable and preserving of beta cell function in children. These data were published in Clinical Immunology and supportive two-year follow-up data from this study were published in the Journal of Translational Medicine,” stated David J. Mazzo, Ph.D., President and Chief Executive Officer of Caladrius Biosciences. “We look forward to reporting the topline data from the primary endpoint of the completed study in early 2019.”
The Phase 2 T-Rex study is being conducted with support from Sanford Research, a Sanford Health subsidiary, a grant from the National Institute of Health and a grant from the California Institute for Regenerative Medicine.
